Data / Medical devices / Brazil / Blue Dent Dental
Blue Dent Dental: FDA-registered device maker in Pirassununga Sao Paulo, Brazil, 1 510(k) clearance
Blue Dent Dental is registered with the FDA (registration 3011618875) in Pirassununga Sao Paulo, Brazil. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 13, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011618875
- Address
- Rua Joaguim Jorge Port, 1272, Pirassununga Sao Paulo, Brazil, 13-636-142
- Owner or operator
- Blue Dent Dental (10055653)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- September 5, 2017
- Registered through
- 2026
- Brand names listed
- CROWN AND BRIDGE, TEMPORARY, RESIN, Denture, plastic, teeth
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Denture, Plastic, Teeth | ELM | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 13, 2018 | K182065 | EVOLUX CAD/CAM PMMA BLOCKS | EBG | Substantially Equivalent | Blue Dent Dental | accessdata.fda.gov |
Compare with other makers
Updated December 13, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.